Assessor, Methodology Biostatistics New

On behalf of our client, we are currently recruiting for an Assessor, Methodology (Biostatistics) - Centralised and Clinical Trials Licensing – Human Products Authorisation and Registration. This is a 3 year fixed term contract role. It is a hybrid role with 2 days per week in the office and 3 days remote. It is a 35 hour week.

ROLE SUMMARY

The Human Products Authorisation and Registration (HPAR) Department provides human medicines licensing services. The Methodology team is part of the Centralised and Clinical Trials licencing section – delivering assessments for products authorised through the centralised (EU) mechanism, and for clinical trials.

The Methodology team consists of clinical pharmacology/pharmacokinetic assessors and biostatisticians/statistical assessors. The position of Assessor, Methodology (Biostatistics) will be based in the Centralised and Clinical Trials licensing section and will report to the Executive Assessor (Methodology).

The Assessor, Methodology (Biostatistics) will use their statistical and professional expertise to lead the assessment and review of the statistical aspects of marketing authorisation applications and clinical trial applications. The assessment involves report writing, contributing to benefit risk assessment. The Assessor, Methodology (Biostatistics) will critically analyse complex clinical and scientific information, making sound judgements on the value of the statistical methodologies employed, and write informative assessment reports for a multi-disciplinary readership.

The Assessor will provide expertise on good drug development, interacting with medical colleagues, multi-disciplinary advisory committees and company representatives, as required. The role holder will also provide in-house statistical expertise to other technical sections in HPAR, as required.

The Assessor will work closely and maintain effective working relationships with members of the Methodology team, other members of the section and with members of the department, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the department are met.

KEY RESPONSIBILITIES

Technical Objectives

· Analyse and critically appraise statistical aspects of pre-marketing applications including dossiers for medicines, scientific advice applications and clinical trial applications and prepare assessment reports

· Assessment includes, but is not limited to, statistical methods, statistical design, statistical analyses plans, sample size and sensitivity analyses and imputation methods for missing data

· Liaise with assessment teams in the assessment of the above-mentioned applications

· Inform and influence National and EU advisory and decision-making committees, including the Advisory Committee for Human Medicines (ACHM) and the Committee for Medicinal Products for Human Use (CHMP)

· Provision of advice to company and to National or EU scientific committees, such as the Scientific Advice Working Party (SAWP) and Methodology Working Party (MWP)

· Contribute to the peer review of national and EU scientific evaluation documents

· Provide statistical advice on behalf of company to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias

· Represent at relevant National and EU meetings, when required

· Maintain and enhance personal and technical competence by keeping abreast of new statistical methodology, occasional analysis of data and other personal development activities

Strategic Objectives

· Support the Section Manager, Executive Assessor (Methodology) and Section Leadership Team in the on-going development of the section

· Work with the Executive Assessor (Methodology) and Section Leadership Team in the development and preparation of work objectives for the section

· Work with the Executive Assessor (Methodology) and Section Leadership Team to prioritise work objectives and to ensure that the operational goals of the Department are achieved

· Provide support and input to colleagues and others within the Section and the department

· Participate in shaping the organisation, strategic visioning, developing the business, innovating and creating

Operational Objectives

· Work with the Executive Assessor (Methodology) and Section Leadership Team to meet the goals and objectives of the section

· Work with the Executive Assessor (Methodology) and Section Leadership Team to plan and organise work tasks that ensure efficient delivery of work

· Assist in the compilation of data and preparation of reports as required

· Promote a positive, open, friendly and professional working environment

· Attend Working Groups/Committees/meetings at the European Medicines Agency (EMA), as required

Quality and Knowledge Management

· Assist the managers of the Section to ensure the effective implementation of the Quality Management System within the section

· Assist the managers of the Section to ensure effective mechanisms are in place to capture, store and communicate key information, experience and knowledge gained by the section

Performance Management

· Participate in the performance development programme (PDP) within the Section to maximise efficiency gains for the department

Communications/Customer Service

· Participate in regular team/section meetings

· Work with colleagues in the Section to maintain positive relationships with stakeholders that reflects the professionalism and high standards of the company in the conduct of assessment and related activities

QUALIFICATIONS AND EXPERIENCE

To be considered for this post, candidates should meet the following criteria:

· A postgraduate qualification (MSc/PhD) (NFQ level 9 or 10) in statistics, medical statistics or biostatistics

· A relevant 3rd level honours degree (NFQ level 8) in mathematical, life science, or healthcare discipline (e.g. mathematics/applied mathematics, biostatistics, statistics, biomedical science, pharmacology, pharmacy, genomics, psychology)

· Experience employing analytical thinking on complex data and statistics, and ability to make appropriate and tailored recommendations, comprehensible by multidisciplinary audience

· Sound understanding of statistical methodology relevant to the regulation of medicines and clinical trials, and emerging methodologies relevant to the field of statistics and medicines regulation

· Knowledge and understanding of the drug development process (pre-clinical, quality, clinical and post-approval) with understanding of drug development as a continuum

· Knowledge and understanding of the clinical trial process, different clinical trial designs and various statistical approaches that may be used

· Experience and knowledge with statistical software packages, standard office software (Word, Excel, PowerPoint), cloud-based platforms (Microsoft Teams) and communication tools (Outlook)

· Ability to evaluate and critically appraise complex information from a variety of sources and make effective decisions

· Self-starter, accountable, capable of effective communication, negotiation and decision making

· Motivated to further develop professional skills and competencies

· Flexible to adapt to changing priorities and take responsibility to ensure success

· Good strategic ability (problem-solving, critical thinking, cross-functional thinking)

· Strong organisational skills, including the ability to prioritise workload

· Excellent oral and written communication skills, excellent attention to detail

· Passion for knowledge sharing and dissemination of statistical expertise, and a willingness to contribute to peer-to-peer learning.

· The ability to work as part of a cross-functional team and clearly communicate statistical issues and methods to multidisciplinary audiences

In addition, the following would be considered an advantage:

· Experience in applying statistical methods in biomedical research, pharmaceutical or CRO industry or drug regulatory agency

· Motivated to quickly develop a sound understanding of a wide range of statistical and clinical trial methodology, including state-of-the-art techniques, relevant to the regulation of medicinal products across the breadth of the drug development process

· Knowledge and experience of centralised licensing and clinical trials regulatory processes

· Experience and knowledge with statistical software packages such as R or SAS

· Knowledge and experience of regulatory (ICH, EMA and FDA) guidelines relating to the regulatory requirements for medicines and clinical trials

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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